Scrutiny of chemical triclosan could lead to FDA rules by 2018

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Major manufacturers call it a powerful germ-killing ingredient for soaps, toothpastes and deodorants, but Susan Kriznik won't allow the man-made chemical triclosan on her shelves at home.

An infection prevention manager at Allegheny General Hospital, she has plenty of company in avoiding products with the antibacterial agent, which federal regulators have put under tougher scrutiny as it shows up in more consumer health and household goods.

“It's the actual time you spend cleaning your hands, with the friction, that actually removes the germs,” Kriznik said.

Manufacturers insist there is no proof the chemical causes bodily harm.

At the Washington-based American Cleaning Institute, a trade group for makers of cleaning products, spokesman Brian Sansoni said the chemical has proved safe and effective in health care settings for more than 40 years.

Some scientists disagree.

“Are antibacterial soaps better than regular soaps? No. There's absolutely no evidence,” said Kishore Alugupalli, an assistant professor of microbiology and immunology at Thomas Jefferson University in Philadelphia. “I'm against any antibacterial substance that is not necessary.”

Under scrutiny

The Food and Drug Administration cast a spotlight in December on triclosan, which emerged as a surgical scrub in the 1970s. It went mainstream as an additive to consumer products in the 1990s and appears in many liquid hand and dishwashing soaps, mouthwashes and cosmetics, among other goods.

Some manufacturers incorporate the chemical into durable items such as earplugs, cutting boards, bath towels and socks. Three in four Americans surveyed in a decade-old study had the chemical in their urine, according to the National Center for Biotechnology Information.

Animal studies suggest long-term exposure to triclosan, which can seep into the bloodstream, could change how hormones work in the human body. Other research raises the prospect that triclosan could help bacteria evolve and become resistant to antibiotics, which might undermine the usefulness of standard medicines, the FDA found.

An FDA proposal would require antibacterial soap makers to prove their consumer products are safe for regular use and more effective than plain soap in preventing illnesses or infections. The agency plans to rule on that proposal by Sept. 15, 2016, spokeswoman Andrea Fischer said.

Manufacturers that don't comply would need to reformulate products or relabel them, according to the agency. The rule would apply to goods containing triclosan and other antibacterial agents such as triclocarban in bar soaps.

“It's pretty clear they're intending to do away with (triclosan) at the consumer level,” said Donald W. Schaffner, a food science professor at Rutgers University in New Brunswick, N.J. “My concern is that use of the product in food service may get caught up in that. It is one very useful tool at our disposal to reduce the risk of food-borne pathogens in food service.”

Science of hygiene

The FDA said it's studying whether triclosan at low concentrations found in consumer products is better at keeping people healthy than conventional scrubbing with basic soap.

“It's one of the most researched, reviewed and regulated ingredients available today,” Sansoni said. His American Cleaning Institute has said evidence and practices do not show triclosan has hormonal effects in humans or that it contributes to antibiotic resistance.

The science behind hand cleaners is subtle, researchers said. They said popular alcohol-based sanitizer gels such as Purell act like a sledgehammer, destroying the bacteria's membrane and killing them immediately. Germs have no chance to develop a resistance to alcohol, a natural agent, they said.

“I actually think they're a very important part of hand hygiene,” said Dr. Carlene Muto, medical director for infection control at Downtown-based UPMC. “An alcohol-based product is an instant kill.”

Triclosan works more slowly and requires longer contact, starving bacteria by putting them under stress, said Alugupalli, the Thomas Jefferson University professor. He said that process allows the micro-organisms to develop mutations that can lead to antibiotic resistance.

UPMC hospitals skirt those issues by using a simple soap in some settings and a specialized product known as chlorhexidine gluconate, or CHG, in others. CHG uses a slow-release approach that stays on the hands long after a good scrub, Muto said.

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